
Regulatory Affairs Coordinator
1 week ago
Recipharm AB is committed to excellence and seeks a dedicated QA Specialist to spearhead our quality assurance initiatives. As a key member of our team, you will be responsible for managing our eQMS, conducting GAP Analyses, and developing high-quality GxP documentation.
Your key responsibilities will include:
- Delivering comprehensive GxP Training programs to equip staff with the necessary skills and knowledge.
- Tracking and analyzing KPIs related to deviations, change controls, CAPAs, and other quality metrics to guarantee the organization meets its quality objectives.
- Identifying and addressing areas for improvement in our SOPs through thorough GAP Analyses and implementing corrective actions accordingly.
- Maintaining accurate and up-to-date GxP documentation, including SOPs, Quality Agreements, training records, and other relevant documents.
- Supporting MHRA/Health Authority inspections, customer audits, and internal audits to ensure successful execution and desired outcomes.
- Fostering a collaborative environment by working closely with the QA team to drive continuous improvements and propose innovative ideas to enhance Site and Quality performance, efficiency, and compliance.
Successful candidates will possess a degree in Quality Management or a related field, extensive knowledge of GMP and GDP, and exceptional organizational skills.
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